EUCTR2016-001928-54-DK进行中（未招募）1 期
A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate Cancer
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 489
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •- ECOG performance status 0-1
- •- Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI).
- •- Ongoing androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone (GnRH) analogue or a surgical/medical castration with testosterone level of =1.73nmol/L (50ng/dL).
- •For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:
- •- Previously randomized to Arm D3 or D4; had histologic confirmation of adenocarcinoma of the prostate and evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria (AJCC criteria) prior to randomization
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 154
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 335
排除标准
- •- Presence of visceral metastases in the liver
- •- Active brain metastases or leptomeningeal metastases
- •- Active, known, or suspected autoimmune disease or infection
- •- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- •For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:
- •- Prior radiation therapy within 14 days prior to first dose of nivolumab combined with ipilimumab.
- •- Have received systemic anti-cancer therapy after the last dose of study treatment (ipilimumab or cabazitaxel).
研究者
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